The Effect of tDCS Combined With TMS on Cognitive Impairment and Motor Function After Stroke

The Effect of Transcranial Electrical Stimulation Combined With Transcranial Magnetic Stimulation on Cognitive Impairment and Motor Function After Stroke

This clinical trial aims to investigate whether transcranial electrical stimulation (tDCS) combined with transcranial magnetic stimulation(TMS) has an impact on the cognitive and motor functions of stroke patients, and to evaluate the safety of this protocol. The main objective is to answer the following question: Can electromagnetic combined stimulation of the left Dorsolateral prefrontal lobe(DLPFC) improve the performance of working memory, motor function and cognitively motor dual tasks in stroke patients? What is its mechanism of action? Participants will undergo a combined real or sham electromagnetic stimulation of 20 minutes of tDCS and 40 seconds of TMS once a day for 7 days. Researchers will compare the effects of real stimulation with sham stimulation to see if the real stimulation can bring better results to patients. Clinical evaluations (cognitive and motor scales) and functional Near-Infrared Spectroscopy(fNIRS) were conducted before and after stimulation to record relevant brain activities

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Cognition Disorders
• Intervention / Treatment: Behavioral: occupational therapy; Other: real tDCS; Other: real TMS; Other: sham tDCS; Other: sham TMS

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanjun Liu; Phone Number: +86 15920175118; Email: lhanjun@mail.sysu.edu.cn
• Study Contact Backup: Name: Jingting Li; Phone Number: +86 13560365827; Email: lijt53@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meeting the diagnostic criteria for hemorrhagic or ischemic stroke in the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases(2nd edition), with the first onset, single hemisphere stroke, and confirmed by CT or MRI,course of diease 1-6 months;
• Age ranging from 30 to 80 years old;
• Native language is Mandarin or Cantonese;
• Right-handed;
• Diagnosed with post-stroke cognitive impairment(PSCI) by the MoCA scale;
• Able to cooperate in completing the speech repetition test;
• Normal hearing.

Exclusion Criteria:

• Currently receiving non-invasive brain stimulation treatment;
• Lesions involving the left DLPFC brain regions;
• History of epilepsy, mental illness,or other neurological or mental disorders;
• Any contraindications for transcranial electrical stimulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: real tDCS-TMS	Behavioral: occupational therapy; occupational therapy 1 hour a day for 7 days; Other: real tDCS; real 20 minutes of tDCS once a day for 7 days; Other: real TMS; 40 seconds of real TMS once a day for 7 days
Sham Comparator: sham tDCS-TMS	Behavioral: occupational therapy; occupational therapy 1 hour a day for 7 days; Other: sham tDCS; sham 20 minutes of tDCS once a day for 7 days; Other: sham TMS; 40 seconds of sham TMS once a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
n-back task accuracy rate	n-back task record accuracy rate	Baseline and 7-days
n-back task reaction time	n-back task record reaction time	Baseline and 7-days
functional connectivity during n-back task	n-back task with fNIRS to record Oxy-Hb concentration	Baseline and 7-days
Verbal fluency test（VFT）accuracy rate	VFT task record accuracy rate	Baseline and 7-days
Verbal fluency test（VFT）reaction time	VFT task record reaction time	Baseline and 7-days
functional connectivity during Verbal fluency test（VFT）	VFT task with fNIRS to record Oxy-Hb concentration	Baseline and 7-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment(MoCA)	MoCA scale(score 0-30, the higher score means the better function)	Baseline and 7-days
isokinetic muscle strength test	isokinetic muscle strength test of knee	Baseline and 7-days

Collaborators and Investigators

• Sponsor: Ke Dong, MD

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Stroke; Cognition Disorders; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Occupational Therapy
• Other Study ID Numbers: Nos.82302848a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: year 2028 data will become available and for 5 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No